1. Field of the Invention
The present invention particularly relates to medical devices and methods that prevent, minimize and/or treat cranial molding in neonatal subjects, most especially for human subjects born prematurely. More particularly, the present invention relates to such medical devices and methods that distribute cranial interface pressures and corresponding forces routinely encountered during care of such neonatal subjects, primarily for reducing risks of cranial deformation and potentially associated developmental impairment or delay.
2. Description of Related Art
As a neonatal human subject lies in a supine position, forces are imparted at areas of contact between the subject and the surface on which the subject lies. When the subject is lying in a supine (back downward) position, a contact area exists generally on the occipital region of the subject's head.
In the mid-1990s, the “Back to Sleep” (BTS) campaign was initiated to address the problem of sudden infant death syndrome (SIDS). It was hypothesized that a risk factor associated with SIDS in infants was sleeping in a prone position and that switching infants to a supine position that the incidence of SIDS would decrease. In one study of 568 SIDS cases occurring before and after the initiation of the BTS campaign in about 1994, a sudden decrease in the rate of SIDS cases from 1.34 per 1,000 births in 1991 to 0.64 per 1,000 births in 2008 occurred. The study also showed that, over that same period, the percentage of SIDS infants placed to sleep prone decreased from 85.4% to 30.1% and that those found prone decreased from 84.0% to 48.5%, whereas those placed supine increased from 1.9% to 47.1%. Such findings indicate overall that more infants were placed supine at the time that the SIDS rate was declining precipitously (Trachtenburg Fla. et al, “Risk Factor Changes for Sudden Infant Death Syndrome After Initiation of Back-to-Sleep Campaign”, Pediatrics 2012; 129; 630).
Largely attributed to the BTS campaign, there has been a simultaneous increase in the occurrence of cranial molding, including deformational plagiocephaly. Deformational plagiocephaly (DP) refers to asymmetry or flattening of the infant skull secondary to external force. While DP has long been an occasional condition in neonatal subjects in general, the incidence of DP has steadily increased over the past twenty years, from an estimated 5% in the mid-1990s to 20-30% currently. Such cranial deformation, unfortunately, may not merely be a cosmetic condition. Evidence suggests that children with deformational plagiocephaly have an increased risk for developmental impairment or developmental delay, perhaps because brain parenchyma shifts to conform to positional skull deformities.
In spite of the long history and steady increase in the incidence of cranial molding, optimal solutions have not been presented. It is known that some orthotics are used in an attempt to ameliorate such conditions, yet the cranial molding rate remains high, and many other challenges and obstacles encountered with the prior art remain unresolved.
Sleep is a critical component of a healing environment in the intensive care unit, especially in the neonatal intensive care unit due to the ongoing neural development of the neonatal patient. For instance, in animal models, it has been shown that sleep deprivation results in a sharp decline in the number of new neurons being developed. Furthermore, the link between pain and sleep quality and the relation of these two to the healing process is well-documented. Insufficient sleep has been shown to sensitize neonatal and pediatric patients to experience pain during periods of wakefulness and that fear and anxiety have a negative impact on sleep. It is noted that adequate sleep supports aspects of tissue repair and aids in the recovery from bouts of pain. With the circular relationship between sleep and pain, improving sleep allows for recovery from pain which in turn promotes better sleep. Of course, the opposite cycle is also in play. Recognizing the critical aspects of sleep in the healing process, the Newborn Individualized Development Care and Assessments (NIDCAP) program has been developed and is an intervention that attempts to minimize the impact on the immature brain from noxious sensory experiences. It seeks to address sleep especially with preterm infants, decreasing sleep fragmentation to improve the development of circadian organization, reduce adverse cardiac stimuli, decrease the amount of bradycardia, apnea and oxygen desaturation, and minimize metabolic needs. Sleep deprivation is an important physiological and psychological stressor, having a negative impact on behavior, breathing, and neuronal development. Providing clinicians with the ability to monitor sleep amounts and quality provides an essential tool for the application of techniques to enhance sleep. Noting that approximately 20% of awakenings in the intensive care unit are due to noise, a program or apparatus that reduces noise may be part of a program to encourage better sleep and with it, better healing.
Many other advantages, disadvantages, problems and challenges of the prior art are known and will be evident to those of ordinary skill in the art, particularly after reading this specification and contemplating its implications.